Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-27 @ 2:37 PM
Study NCT ID:
NCT05316792
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Case-Control Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-30', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-03-30', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonographic Evaluation', 'timeFrame': 'just before walking', 'description': 'Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.'}, {'measure': 'Ultrasonographic Evaluation', 'timeFrame': 'within 5 minutes after loading condition', 'description': 'Femoral joint cartilage thickness will be measured with portable USG with telemedicine feature.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee osteoarthritis', 'Cartilage', 'Ultrasonography'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to measure and compare the femoral cartilage deformation after walking on the treadmill and tartan floor in patients with knee osteoarthritis (OA) and healthy volunteers.', 'detailedDescription': "The investigators will recruit 30 patients who will be applied to Physical Medicine and Rehabilitation outpatient clinic and diagnosed with knee OA according to American College of Rheumatology (ACR) criteria and 30 healthy volunteers matched for age and gender. The sociodemographic characteristics and detailed history of the patients included in the study will be questioned and recorded. After a detailed physical examination of all patients, weight and height will be measured, and body mass indexes (BMI) will be calculated. Participants' physical activity levels will be determined based on the World Health Organization's Global Physical Activity Questionnaire. This questionnaire has been reported to provide a valid and reliable estimate of physical activity, Turkish validity and reliability have been established.\n\nA repeated measures design will be used in which healthy volunteers and patients with knee OA all complete all loading conditions (30min walking on the treadmill and tartan floor). For this, each group (healthy volunteers and knee OA patients) will first walk on the treadmill and then do tartan ground walking 1 week later. Femoral articular cartilage thickness before and immediately after walking will be measured with portable ultrasonography (USG) with a telemedicine feature.\n\nUpon arrival at the treatment unit or area of the tartan track, participants will sit on a treatment table with their knees fully extended for 30 minutes to minimize the effects of previous activity on cartilage. All sessions will be completed at the same time of day to reduce daily variations in cartilage thickness. The dominant leg will be defined as the self-reported limb that the participant chooses to use to kick a ball. All post-load USG procedures will be achieved within 5 minutes after the loading condition. 3 images will be taken from each participant.\n\nTwo separate evaluators will measure to determine the reliability among the measurers.\n\nTo equalize the loading, the speed at which each participant walks on the treadmill in 30 minutes will be determined by the pedometer as a brisk walking speed (5 km/h). Again, each participant will walk on the tartan floor with a pedometer and walk for 30 minutes at an equal distance at the same pace as on the treadmill. The pedometer will give a warning when it is below or above the desired speed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be over 40 years old\n* Having been diagnosed with knee OA according to the ACR diagnostic criteria\n* Being diagnosed with stage 1-2 knee OA according to the Kellgren-Lawrence staging criteria\n\nExclusion Criteria:\n\n* Having a musculoskeletal or systemic disease that will prevent the exercise\n* History or symptoms of lower extremity surgery, ligament injury, balance disorder, lower extremity injury in the last 6 months\n* Presence of psychiatric or neurological disease affecting cooperation, cognitive and neurological functions'}, 'identificationModule': {'nctId': 'NCT05316792', 'briefTitle': 'Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking', 'organization': {'class': 'OTHER', 'fullName': 'Pamukkale University'}, 'officialTitle': 'Evaluation of Femoral Cartilage Thickness After Treadmill and Tartan Track Walking in Healthy Individuals and Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'PamukkaleU-Simsek-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'knee osteoarthritis', 'description': 'In patients with knee osteoarthritis, the thickness of the femoral articular cartilage will be measured with portable USG before and immediately after walking.', 'interventionNames': ['Other: walking']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'healthy volunteers', 'description': 'Femoral articular cartilage thickness will be measured with portable USG before and immediately after walking in healthy volunteers.', 'interventionNames': ['Other: walking']}], 'interventions': [{'name': 'walking', 'type': 'OTHER', 'description': '30 min walking on the treadmill and tartan floor', 'armGroupLabels': ['healthy volunteers', 'knee osteoarthritis']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ayse Simsek, m.d.', 'role': 'CONTACT', 'email': 'draysesimsek2@gmail.com', 'phone': '+905319698492'}], 'overallOfficials': [{'name': 'Hakan Alkan, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pamukkale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pamukkale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Hakan Alkan', 'investigatorAffiliation': 'Pamukkale University'}}}}